Metabolic DiseasesNCT06060509
Study on the Effects of Wheat and Corn Germ Blend Oil on Antioxidation and Immune Regulation of Dyslipidemia Population
A study testing Phytosterol-rich Wheat and Corn Germ Blended Oil and Peanut oil in people with Metabolic Diseases and Immune System Disorder, run by Southeast University, China at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the role of wheat and corn germ blended oils in regulating oxidative stress and immunomodulation in dyslipidaemic populations, to explore their effects on intestinal flora, antioxidant and immunomodulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases, Immune System Disorder, Dyslipidemias
- What is being tested?
- Phytosterol-rich Wheat and Corn Germ Blended Oil and Peanut oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18-65 with BMI less than 30;
- At least one item meets the diagnostic criteria for dyslipidemia (2016 Chinese adult dyslipidemia prevention and treatment guide)
- No serious complications related to liver, kidney, digestive tract, endocrine diseases and chronic diseases;
- Within 3 months, he did not use the drugs and dietary supplements related to reducing blood fat and weight, and agreed not to use the above foods or drugs during the experiment;
- Volunteer to participate in this study after listening to the project introduction and sign the informed consent form.
Who cannot join
- Pregnant, pregnant or lactating women;
- Patients with liver and kidney dysfunction, diabetes, coronary heart disease, hyperthyroidism, malignant tumor, asthma and other chronic diseases other than dyslipidemia;
- Endocrine disease patients, postoperative patients, patients receiving hormone therapy and psychotic patients;
- Have special eating habits: vegetarian, ketogenic diet (high fat, low carbon water), etc;
- Those who cannot follow the test requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Phytosterol-rich Wheat Corn Germ Blended Oil on Immune Function, Oxidative Stress, Serum Metabolites and Intestinal Flora in Dyslipidaemic Population: A Randomised Controlled Trial
The goal of this clinical trial is to explore the role of wheat and corn germ blended oils in regulating oxidative stress and immunomodulation in dyslipidaemic populations, to explore their effects on intestinal flora, antioxidant and immunomodulation. The main questions it aims to answer are:
- How does phytosterol-rich wheat corn germ blended oil affect oxidative stress and immune function in dyslipidaemic people compared to peanut oil?
- How does phytosterol-rich wheat corn germ blended oil affect serum metabolites, serum fatty acid profile, and intestinal flora in dyslipidaemic populations compared to peanut oil? What are the specific mechanisms involved?
Read more
Participants will be randomly assigned to the intervention and control groups, the packaging of germ oil and peanut oil will have a uniform appearance, and participants will be instructed to replace their household cooking oils with the distributed cooking oil for three months, in addition to replacing all the canteens in the staff units with the trial oil for more than three months. Participants did not know who was the control oil, germ oil or peanut oil, and both were randomly distributed to different groups of participants by the third-party supervisors.
Researchers will compare peanut oil to see if phytosterol-rich germ oil can improve oxidative stress and immune function in dyslipidaemic populations, in addition to exploring possible underlying mechanisms of improvement using multi-omics techniques.
Read the detailed description
The design of this intervention trial was a randomised controlled trial, in which the included dyslipidaemic population was randomly divided into a wheat corn germ blended oil intervention group and a peanut oil control group, with the male/female ratio, age, and level of basic clinical characteristics balanced between the two groups. The entire test phase consisted of a 14-day washout period and a 3-month intervention period. Participants in the intervention and control groups first entered a 14-day peanut oil washout period, which was followed by a three-month intervention phase. During the intervention phase, two different cooking oils (25-30 g of cooking oil per day according to the recommended intake of the Chinese Nutrition Society) were allocated to the two groups, with peanut oil being consumed by participants in the control group, and germ oil being used to replace the daily cooking oil for participants in the intervention group. After the participants were randomised into groups, they were provided with lunch and dinner according to the Chinese Dietary Guidelines for Residents of China and the local dietary habits of Nanjing, China, and breakfast was provided by the subjects themselves (dietary guidance was given to the subjects during the course of the study, and breakfast recipes were provided uniformly in order to achieve consistency between the two groups), and the intervention period was 3 months. Throughout the project period, all subjects followed their normal dietary habits and maintained a normal level of physical activity.
- Conditions
- Metabolic Diseases, Immune System Disorder, Dyslipidemias, Fatty Acid Metabolism Disorder, Oxidative Stress
- Being tested
- Phytosterol-rich Wheat and Corn Germ Blended Oil, Peanut oil
- Keywords
- germ blend oil, Gut Microbiota, lipidomics, anti-oxidation, immune regulation, phytosterol
- Medical subject headings
- Metabolic Diseases, Immune System Diseases, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phytosterol-rich Wheat and Corn Germ Blended OilDietary supplement
Blending of corn germ oil and wheat germ oil supplied by Yihai Kerry to obtain germ blended oil with high phytosterol content.
Peanut oilDietary supplement
Participants in the control group consumed peanut oil daily for cooking.
| Study group | Role | What they receive |
|---|---|---|
| Wheat corn germ blended oil group | Experimental | Participants in the intervention group replaced the daily cooking oil with wheat and corn germ oil, and were given 25-30 g of cooking oil per day according to the recommended intake of the Chinese Nutrition Society. Lunch and dinner were cooked using a uniform recipe for both intervention and control groups, and breakfast was self-cooked under the uniform dietary guidelines. Receives: Dietary Supplement: Phytosterol-rich Wheat and Corn Germ Blended Oil |
| Peanut oil group | Other | Participants in the Peanut oil group replaced the daily cooking oil with Peanut oil, and were given 25-30 g of cooking oil per day according to the recommended intake of the Chinese Nutrition Society. Lunch and dinner were cooked using a uniform recipe for both intervention and control groups, and breakfast was self-cooked under the uniform dietary guidelines. Receives: Dietary Supplement: Peanut oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height in metres
Height in metres, physiological parameter
Measured: 12 weeks
Weight in kilogram
physiological parameter
Measured: 12 weeks
body mass index (BMI)
BMI= Weight (kg)/height^2(m)
Measured: 12 weeks
waist circumference
Unit in centimetres,physiological parameter
Measured: 12 weeks
hip measurement
Unit in centimetres,physiological parameter
Measured: 12 weeks
Systolic blood pressure
Units in mmHg. physiological parameter.
Measured: 12 weeks
diastolic blood pressure
Units in mmHg. physiological parameter.
Measured: 12 weeks
Serum triglyceride concentrations
physiological parameter
Measured: 12 weeks
Serum triglycerides concentrations
physiological parameter
Measured: 12 weeks
Serum LDL cholesterol concentrations
physiological parameter
Measured: 12 weeks
Serum HDL cholesterol concentrations
physiological parameter
Measured: 12 weeks
Percentage of CD3+ total T cells
physiological parameter
Measured: 12 weeks
Percentage of CD4+ T cells
physiological parameter
Measured: 12 weeks
Percentage of CD8+ T cells
physiological parameter
Measured: 12 weeks
Percentage of CD4+ CD8+ cells
physiological parameter
Measured: 12 weeks
Percentage of CD19+ B cells
physiological parameter
Measured: 12 weeks
Percentage of CD16/56+ NK cells
physiological parameter
Measured: 12 weeks
Immunoglobulin G
physiological parameter
Measured: 12 weeks
Immunoglobulin A
physiological parameter
Measured: 12 weeks
Immunoglobulin M
physiological parameter
Measured: 12 weeks
Complement C3
physiological parameter
Measured: 12 weeks
Immunoglobulin E
physiological parameter
Measured: 12 weeks
reactive oxygen species
physiological parameter
Measured: 12 weeks
superoxide dismutase
physiological parameter
Measured: 12 weeks
malondialdehyde
physiological parameter
Measured: 12 weeks
glutathione
physiological parameter
Measured: 12 weeks
Secondary outcomes (7)
Lipoprotein a
physiological parameter
Measured: 12 weeks
leptin
physiological parameter
Measured: 12 weeks
Transforming growth factor-β
physiological parameter
Measured: 12 weeks
diamine oxidase
physiological parameter
Measured: 12 weeks
endotoxin
physiological parameter
Measured: 12 weeks
Number of participants who smoke
questionnaire
Measured: 12 weeks
Number of participants taking lipid-lowering drugs
questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Mar 2023
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised controlled intervention trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Nutrition Society, Zhongda Hospital
- Responsible party
- Principal investigator, Jia-yue Xia, Southeast University, China
- Investigators
- Gui-ju Sun, phD, Study director, Chinese Nutrition Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060509
- Sponsor's protocol ID
- 2022ZDSYLL031-P02
- Other IDs
- CNS-NNSRG2021-39
- Status last verified
- Oct 2024
- First submitted
- 19 Sep 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There's no plan for that yet.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phytosterol-rich Wheat Corn Germ Blended Oil on Immune Function, Oxidative Stress, Serum Metabolites and Intestinal Flora in Dyslipidaemic Population: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06060509
- Acronym / sponsor ID
- 2022ZDSYLL031-P02
- Conditions
- Metabolic Diseases, Immune System Disorder, Dyslipidemias, Fatty Acid Metabolism Disorder, Oxidative Stress
- Keywords
- germ blend oil, Gut Microbiota, lipidomics, anti-oxidation, immune regulation, phytosterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Chinese Nutrition Society, Zhongda Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to explore the role of wheat and corn germ blended oils in regulating oxidative stress and immunomodulation in dyslipidaemic populations, to explore their effects on intestinal flora, antioxidant and immunomodulation. The main questions it aims to answer are:
- How does phytosterol-rich wheat corn germ blended oil affect oxidative stress and immune function in dyslipidaemic people compared to peanut oil?
- How does phytosterol-rich wheat corn germ blended oil affect serum metabolites, serum fatty acid profile, and intestinal flora in dyslipidaemic populations compared to peanut oil? What are the specific mechanisms involved?
Participants will be randomly assigned to the intervention and control groups, the packaging of germ oil and peanut oil will have a uniform appearance, and participants will be instructed to replace their household cooking oils with the distributed cooking oil for three months, in addition to replacing all the canteens in the staff units with the trial oil for more than three months. Participants did not know who was the control oil, germ oil or peanut oil, and both were randomly distributed to different groups of participants by the third-party supervisors.
Researchers will compare peanut oil to see if phytosterol-rich germ oil can improve oxidative stress and immune function in dyslipidaemic populations, in addition to exploring possible underlying mechanisms of improvement using multi-omics techniques.
Detailed description
The design of this intervention trial was a randomised controlled trial, in which the included dyslipidaemic population was randomly divided into a wheat corn germ blended oil intervention group and a peanut oil control group, with the male/female ratio, age, and level of basic clinical characteristics balanced between the two groups. The entire test phase consisted of a 14-day washout period and a 3-month intervention period. Participants in the intervention and control groups first entered a 14-day peanut oil washout period, which was followed by a three-month intervention phase. During the intervention phase, two different cooking oils (25-30 g of cooking oil per day according to the recommended intake of the Chinese Nutrition Society) were allocated to the two groups, with peanut oil being consumed by participants in the control group, and germ oil being used to replace the daily cooking oil for participants in the intervention group. After the participants were randomised into groups, they were provided with lunch and dinner according to the Chinese Dietary Guidelines for Residents of China and the local dietary habits of Nanjing, China, and breakfast was provided by the subjects themselves (dietary guidance was given to the subjects during the course of the study, and breakfast recipes were provided uniformly in order to achieve consistency between the two groups), and the intervention period was 3 months. Throughout the project period, all subjects followed their normal dietary habits and maintained a normal level of physical activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomised controlled intervention trial.
| Arm | Type | Receives |
|---|---|---|
| Wheat corn germ blended oil group | Experimental | Dietary Supplement: Phytosterol-rich Wheat and Corn Germ Blended OilParticipants in the intervention group replaced the daily cooking oil with wheat and corn germ oil, and were given 25-30 g of cooking oil per day according to the recommended intake of the Chinese Nutrition Society. Lunch and dinner were cooked using a uniform recipe for both intervention and control groups, and breakfast was self-cooked under the uniform dietary guidelines. |
| Peanut oil group | Other | Dietary Supplement: Peanut oilParticipants in the Peanut oil group replaced the daily cooking oil with Peanut oil, and were given 25-30 g of cooking oil per day according to the recommended intake of the Chinese Nutrition Society. Lunch and dinner were cooked using a uniform recipe for both intervention and control groups, and breakfast was self-cooked under the uniform dietary guidelines. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18-65 with BMI less than 30;
- At least one item meets the diagnostic criteria for dyslipidemia (2016 Chinese adult dyslipidemia prevention and treatment guide)
- No serious complications related to liver, kidney, digestive tract, endocrine diseases and chronic diseases;
- Within 3 months, he did not use the drugs and dietary supplements related to reducing blood fat and weight, and agreed not to use the above foods or drugs during the experiment;
- Volunteer to participate in this study after listening to the project introduction and sign the informed consent form.
Key exclusion criteria (5 listed)
- Pregnant, pregnant or lactating women;
- Patients with liver and kidney dysfunction, diabetes, coronary heart disease, hyperthyroidism, malignant tumor, asthma and other chronic diseases other than dyslipidemia;
- Endocrine disease patients, postoperative patients, patients receiving hormone therapy and psychotic patients;
- Have special eating habits: vegetarian, ketogenic diet (high fat, low carbon water), etc;
- Those who cannot follow the test requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phytosterol-rich Wheat and Corn Germ Blended OilBlending of corn germ oil and wheat germ oil supplied by Yihai Kerry to obtain germ blended oil with high phytosterol content. | Dietary supplement | Wheat corn germ blended oil group |
| Peanut oilParticipants in the control group consumed peanut oil daily for cooking. | Dietary supplement | Peanut oil group |
Primary outcome
Height in metres
Time frame: 12 weeks
Height in metres, physiological parameter
Weight in kilogram
Time frame: 12 weeks
physiological parameter
body mass index (BMI)
Time frame: 12 weeks
BMI= Weight (kg)/height^2(m)
waist circumference
Time frame: 12 weeks
Unit in centimetres,physiological parameter
hip measurement
Time frame: 12 weeks
Unit in centimetres,physiological parameter
Systolic blood pressure
Time frame: 12 weeks
Units in mmHg. physiological parameter.
diastolic blood pressure
Time frame: 12 weeks
Units in mmHg. physiological parameter.
Serum triglyceride concentrations
Time frame: 12 weeks
physiological parameter
Serum triglycerides concentrations
Time frame: 12 weeks
physiological parameter
Serum LDL cholesterol concentrations
Time frame: 12 weeks
physiological parameter
Serum HDL cholesterol concentrations
Time frame: 12 weeks
physiological parameter
Percentage of CD3+ total T cells
Time frame: 12 weeks
physiological parameter
Percentage of CD4+ T cells
Time frame: 12 weeks
physiological parameter
Percentage of CD8+ T cells
Time frame: 12 weeks
physiological parameter
Percentage of CD4+ CD8+ cells
Time frame: 12 weeks
physiological parameter
Percentage of CD19+ B cells
Time frame: 12 weeks
physiological parameter
Percentage of CD16/56+ NK cells
Time frame: 12 weeks
physiological parameter
Immunoglobulin G
Time frame: 12 weeks
physiological parameter
Immunoglobulin A
Time frame: 12 weeks
physiological parameter
Immunoglobulin M
Time frame: 12 weeks
physiological parameter
Complement C3
Time frame: 12 weeks
physiological parameter
Immunoglobulin E
Time frame: 12 weeks
physiological parameter
reactive oxygen species
Time frame: 12 weeks
physiological parameter
superoxide dismutase
Time frame: 12 weeks
physiological parameter
malondialdehyde
Time frame: 12 weeks
physiological parameter
glutathione
Time frame: 12 weeks
physiological parameter
7 secondary outcomes
Lipoprotein a
Time frame: 12 weeks
leptin
Time frame: 12 weeks
Transforming growth factor-β
Time frame: 12 weeks
diamine oxidase
Time frame: 12 weeks
endotoxin
Time frame: 12 weeks
Number of participants who smoke
Time frame: 12 weeks
Number of participants taking lipid-lowering drugs
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No. There's no plan for that yet.
Related trials for Metabolic Diseases
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gui-ju Sun, phD study director
Chinese Nutrition Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytosterol-rich Wheat and Corn Germ Blended Oil and Peanut oil in people with Metabolic Diseases and Immune System Disorder, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height in metres (time frame: 12 weeks). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.